一种新的涂层15毫克普莱马奎因配方用于消除疟疾的生物等价性
Julie Nguyen Ngoc Pouplin1, Thoopmanee Kaendiao2, Bilal Ahmad Rahimi3
1Réseau Médicaments et Développement, 21Bis Avenue du Commandant l'Herminier, 44600, Saint-Nazaire, France. julie.nguyen@remed.org.
Malaria journal
|June 5, 2024
概括
一个新的IPCA普莱马奎因片被发现与Sanofi参考产品具有生物等价性. 这为疟疾消除计划提供了质量可靠的选择,增加了primaquine的可用性.
科学领域:
- 药理动力学和生物等价性研究
- 疟疾药物开发 疟疾药物开发
- 全球卫生 制药 制药品
背景情况:
- 质量保证的15毫克普莱马奎因片的有限可用性阻碍了消除疟疾的努力.
- 目前市场上只有一个严格的监管机构注册的普里马基因片.
- 增加可靠普莱马奎因的获取对于全球疟疾控制至关重要.
研究的目的:
- 为了评估测试15毫克普莱马奎因片 (IPCA) 与参考15毫克普莱马奎因片 (Sanofi) 的生物等价性.
- 为了确定IPCA的primaquine配方是否符合治疗等价性的生物等价性标准.
- 支持IPCA的潜在注册和计划性使用,用于消除疟疾.
主要方法:
- 一个随机的,两个序列的交叉研究,涉及18-45岁的健康志愿者.
- 参与者在空腹时接受了测试或参考15毫克的普莱马奎因.
- 在72小时内使用LC-MS/MS测量了普里马基因和碳氧普里马基因的血度.
主要成果:
- 在50名志愿者中,有47人完成了这项研究,15毫克的IPCA普莱马奎因与桑诺菲参考产品具有生物等价性.
- 峰值度 (Cmax) 的几何平均值 (GM) 比率为104.17% (90% CI:96.92-111.96%).
- 曲线下面积的转基因比例 (AUC0-t) 为105.76% (90% CI:99.76-112.08%),具有类似的药理动力学特征.
结论:
- 15毫克的IPCA普莱马奎因与15毫克的赛诺菲普莱马奎因具有生物等价性.
- 这一发现支持IPCA在疟疾流行国家进行前期资格和注册.
- 这项研究为在疟疾消除策略中更广泛地使用皮马奎因铺平了道路.
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